The prevalence of overweight and obesity is increasing at an alarming rate, and obesity has become one of the most important avoidable risk factors for morbidity and mortality. Based on a healthy body mass index (BMI), about one-third of the US adults are considered obese (BMI≥30 kg/m2) and an additional third is overweight (BMI≥25 kg/m2). Due to the medical and psychosocial impact of being overweight, as well as the difficulty in making sustained improvements in diet and physical activity, patients often turn to over-the-counter (OTC) proprietary weight-loss products containing single or multiple dietary supplements (e.g., herbs, vitamins, minerals, amino-acids).
Another approach to induce weight loss is to increase satiation and reduce the urge for food intake by administering devices that swell in the stomach and after residence time therein are evacuated through the GI (gastrointestinal tract). Such commercial products are: “Formoline” (Certmedica International GMBH), “CM3” (Easyway GMBH), “The Fill Pill” (Holms Enterprises Inc.), “Zalak B” (Arcadia Herba Ltd.), “Avantrx” (Biosyntrx, Inc.), “PREE” (Wellosophy Corp.).
The efficiency of most of these known devices depends on parameters such as: extent of swellability of the device in situ, device size and/or specific shape to ensure device residence in the stomach for minimum time period, strength of the swelled device to withstand excessive gastric pressures, strength of the device to stimulate the mechanoreceptors on the stomach wall, ability to encase the device into a swollowable size capsule, ability of the device to create large and effective volume in the stomach, ability of the device size and shape to imitate stomach functioning to the existing of solid parts and to delay the content emptying, compatibility with dynamic gastric changes (pH, conductivity, water content, foods and drugs), capability of the device to decline and pass the pylorus (a barrier between the gastric and intestine) after residence time in the stomach, degradation in the intestine to avoid GI obstractions.